Spiggle & Theis Injection Needles Recalled Due to Cytotoxicity Risk
Spiggle & Theis Mt Gmbh is recalling two models of injection needles due to elevated cytotoxicity values that may cause allergic or intolerance reactions. The affected products were distributed in California, Connecticut, Missouri, and Ohio.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard—elevated cytotoxicity presenting a risk of allergic or intolerance reactions—is a direct harm risk without documented patient harm to date, qualifying as a risk-of-harm product under the High severity classification.
Plain-English summary
Spiggle & Theis Mt Gmbh is recalling two models of non-sterile, bayonet injection needles with Luer-Lock connectors: Model 50-353-23 (working length 25 cm, total length 31 cm) and Model 50-345-23 (working length 24 cm, total length 31 cm).
The recalled needles exhibit elevated cytotoxicity values. Use of these needles may present a risk of intolerance reaction or allergic reaction in patients.
The affected products were distributed nationwide in California, Connecticut, Missouri, and Ohio.
The recalled product
- Product
- Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
- Manufacturer
- Spiggle & Theis Mt Gmbh
- Hazard
- cytotoxicity
- allergic-reaction
- intolerance-reaction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 1. Model No 50-353-23
- UDI-DI 04250381858806
- LOT (0)2241239 2. Model No 50-345-23
- UDI-DI 04250381858813
- LOT 2230438
- LOT 2240251
Distribution
Distributed nationwide across the United States.
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